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TAIWAN

Entering the Taiwan market offers a promising gateway for medical device manufacturers, particularly those with advanced and innovative products. However, successfully navigating its distinct regulatory framework demands strategic planning.

The Taiwan Food and Drug Administration (TFDA), under the Ministry of Health and Welfare, serves as the competent authority responsible for medical device registration, market surveillance, and quality system oversight. The TFDA enforces a robust regulatory regime that, while sharing some similarities with other major markets, has its own unique requirements, classification rules, and approval pathways.

Consequently, collaborating with a local partner who possesses deep regulatory expertise and on-the-ground experience is not just beneficial, but often a critical component for achieving efficient and compliant market access.

Definition of medical devices

Medical devicesl refer to instruments, machines, apparatus, materials, software, reagents for in vitro use, and related articles thereof, whose design and use achieve one of the following primary intended actions in or on the human body by other than pharmacological, immunological, metabolic, or chemical means:

  • Diagnosis, treatment, alleviation, or direct prevention of human diseases.
  • Modification or improvement of the structure and function of human body.
  • Control of conception.

Classification

  • Class I devices – Low risk: Medical devices that implements routine management which can ensure their safety and effectiveness.
  • Class II medical device – Moderate risk: Medical devices that requires strict control and management to ensure their safety and effectiveness.
  • Class III devices – High risk: Medical devices that requires special measures to strictly control and manage them to ensure their safety and effectiveness.

Competent Authorities and Registration Process

Type of medical device The Registration Pathway Regulatory Authority
Class I devices Listing TFDA
Class I medical devices fall under the catalog published by the TFDA ·         Stage 1: Quality system documentation (QSD) Registration

Except for products exempted from manufacturing licensing requirements as listed in the catalog published by the TFDA.

·         Stage 2: Registration and Market Approval
Class II, III devices ·         Stage 1: Quality system documentation (QSD) Registration

Except for products exempted from manufacturing licensing requirements as listed in the catalog published by the TFDA.

·         Stage 2: Registration and Market Approval

Options for registration applicant

Our Services

Registration service

Registration service

Registration service

With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.

Circulation number entrustment service

Marketing Authorization Holder (MAH) Service

Marketing Authorization Holder (MAH) Service

If enterprises are concerned about the cost of establishing a legal entity in Taiwan or wish to avoid granting exclusive distribution rights to a local partner, MedNovum offers a flexible and optimal solution. Through our trusted partner based in Taiwan, we provide MAH service, supporting enterprises in submitting registration applications as designated, while helping them maintain control over product management and market.

Regulatory compliance consulting services

Regulatory Compliance Consulting Service

Regulatory Compliance Consulting Service

-Language barriers and the complexity of local regulations often pose challenges for enterprises entering new markets. Don’t worry — with MedNovum’s specialized consulting services, we ensure your compliance from the initial market entry stage through post-market activities.

MEDNOVUM

YOUR COMPREHENSIVE PARTNER IN THE MEDICAL DEVICES SECTOR

1

HUMAN RESOURCES

MedNovum brings together a team of experienced experts, including lawyers, pharmacists, and engineers who are extensively trained in the field of medical devices. With a strong knowledge base and deep understanding of legal regulations, technical procedures, and market requirements across multiple countries, we are confident in delivering comprehensive, accurate, and effective service solutions to every client. The combination of legal expertise and technical proficiency is what sets MedNovum apart, making us a trusted partner for many years.

2

ISO CERTIFICATE

Achieving the ISO 9001:2015 certification is an important milestone in MedNovum’s development journey. This achievement shows our strong commitment to maintaining high-quality services, meeting customer expectations, and strengthening MedNovum’s position in the medical device market.

3

NUMBER OF YEARS OF EXPERIENCE

With over 10 years of experience in the medical device industry, we understand the needs and challenges that businesses face. MedNovum is committed to providing professional, accurate, and reliable services – helping our clients save time, ensure regulatory compliance, and improve business performance.